NCT06676696招募中4 期
A Multi-centre, Open, Prospective, Randomized, Parallel-group, 24-month Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年1月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Degree of HLA sensitization
研究概览
简要总结
The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
The main question this study aims to answer is:
Does maintaining long-term immunosuppression in patients with a late renal graft failure (> 3 months) safely reduce the risk of HLA sensitization?
To answer this question, patients will be assigned to a control arm or investigational arm:
- Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.
- Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years.
Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be able to understand and provide written informed consent
- •Patients older than 18 years who had received at least one previous renal transplant
- •Patients with a retained kidney graft failed for any reason which survived at least 3 months
- •Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted
- •Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria
- •Patients taking immunosuppressants tacrolimus or cyclosporine
- •cPRA at the time of randomization ≤ 90%
排除标准
- •Patients who have received another solid organ transplantation (liver, lung, heart or pancreas)
- •Patients waiting for a living related / unrelated kidney transplant
- •Graft survival of the failed graft lower than 3 months
- •Patients in dialysis more than 6 months at the time of randomization
- •Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria
- •Pregnant women
- •Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Patients should use one of the acceptable birth control measures recommended in the document "Recommendations related to contraception and pregnancy testing in clinical trials" published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21/09/2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.
研究组 & 干预措施
Control Arm
Active Comparator
干预措施: Calcineurin inhibitor withdrawal at 6 months (Drug)
Investigational arm
Active Comparator
干预措施: Continue low dose calcineurin inhibitor (CNI) (Drug)
结局指标
主要结局
Degree of HLA sensitization
时间窗: 2 years
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
次要结局
- Mortality for any reason(2 years)
- Days of hospitalization for any reason(2 years)
- Percentage of patients effectively relisted during follow-up(2 years)
- Percentage of patients transplanted(2 years)
- Percentage of patients delisted for any reason(2 years)
- Incidence of infection(2 years)
- Incidence of cardiovascular events(2 years)
- Incidence of cancer(2 years)
- Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft(2 years)
- Erythropoietin resistance index(2 years)
- Residual renal function(2 years)
- Number of circulating memory B-cells(2 years)
- Adverse events(2 years)
研究者
研究点 (1)
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